Smilow Cancer Hospital Care Center

Researchers are evaluating the effects of pembrolizumab alone compared to the standard treatment of chemotherapy cisplatin or carboplatin combined with radiation therapy after surgery in patients with recurrent or second primary head and neck squamous cell carcinoma. This phase II trial aims to assess overall survival, disease control, metastasis rates, and side effects in high-risk patients, while also exploring whether high PD-L1 expression predicts better responses to pembrolizumab. Participants are randomly assigned to one of two treatment groups. One group receives intravenous cisplatin or carboplatin weekly for six cycles alongside daily intensity-modulated radiation therapy or proton beam radiation totaling 30 sessions. The other group receives intravenous pembrolizumab every six weeks for up to nine cycles. Throughout treatment, participants undergo CT or MRI scans to monitor their condition. After completing treatment, participants are followed up 30 days later and then every six months for up to five years. During the study, researchers evaluate overall survival from randomization to death, adverse events for up to five years, disease-free survival, and PD-L1 expression levels. The study monitors patients closely with imaging and clinical assessments to track treatment effects and safety over time.

This research aims to evaluate how well amivantamab given by subcutaneous injection works in treating patients with advanced non-small cell lung cancer that has extra copies of the MET gene. This phase II Expanded Lung-MAP treatment trial focuses on patients with MET amplification-positive non-small cell lung cancer. The goal is to see if amivantamab-SC can reduce tumor growth or spread by targeting the extra MET gene copies in these tumors. Participants receive amivantamab subcutaneously on days 1, 8, 15, and 22 during the first 28-day cycle, then on days 1 and 15 of subsequent 28-day cycles as long as the disease does not progress or unacceptable side effects occur. Throughout the trial, patients have regular CT or MRI scans and blood samples taken to monitor treatment effects and disease status. After completing treatment, patients are followed for up to 3 years to assess long-term outcomes. During the study, researchers evaluate how many patients respond to the treatment, how long responses last, progression-free survival, overall survival, and the frequency and severity of side effects. Blood samples are collected before treatment, during therapy, and at disease progression to study tumor DNA and build a tissue and blood repository. Safety labs, physical exams, and performance status assessments are also conducted. The total participation can last up to 3 years including follow-up.

Researchers are evaluating the addition of pembrolizumab immunotherapy to standard chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer NSCLC that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival among different treatment approaches, including chemotherapy alone, chemotherapy followed by pembrolizumab, and chemotherapy combined with pembrolizumab. The study also assesses quality of life and adverse event rates in these patient groups. Participants are randomly assigned to one of three groups. One group receives only chemotherapy with observation afterward. The other two groups receive chemotherapy followed by pembrolizumab or chemotherapy combined with pembrolizumab. Chemotherapy involves one of four platinum doublet regimens administered every 21 days for four cycles, depending on the physicians choice. Pembrolizumab is given intravenously over 25-40 minutes, either after chemotherapy or alongside it, repeated every 21 days or every 6 weeks for multiple cycles. Patients also undergo heart ultrasound, MRI, CT scans, and blood sample collections as part of the study. During the trial, participants have regular medical assessments including imaging and blood tests to monitor their health. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years from randomization. Researchers measure disease-free survival as the main outcome, tracking the time until cancer recurrence or death. They also evaluate overall survival, side effects, drug tolerability, and patient-reported quality of life over time.

Researchers are evaluating treatment options for patients newly diagnosed with multiple myeloma who are considered frail or intermediate-fit and who are not candidates for stem cell transplant. This phase III trial compares three different three-drug induction regimens followed by either single or double drug maintenance therapies. The study aims to find which drug combination best controls the cancer and improves patient outcomes while considering patients age, other health conditions, and physical function. Participants are randomly assigned to one of three treatment arms. In Arm 1, patients receive bortezomib, lenalidomide, and dexamethasone with bortezomib given subcutaneously and the others taken orally for up to 9 cycles, followed by lenalidomide maintenance. Arm 2 involves daratumumab with hyaluronidase-fihj given subcutaneously, lenalidomide, and dexamethasone for induction, followed by lenalidomide maintenance. Arm 3 includes the same induction as Arm 2, but maintenance therapy combines daratumumab with hyaluronidase-fihj and lenalidomide. Each cycle lasts 28 days, and treatment continues without disease progression or unacceptable side effects. During the trial, participants undergo regular assessments including tumor measurements, blood tests, and quality-of-life questionnaires. Researchers monitor progression-free survival, overall survival, response rates, minimal residual disease status, and patient-reported symptoms and health status. After completing treatment, patients are followed up every 3 months for one year, every 6 months for two years, and then annually for up to 10 years to monitor long-term outcomes and safety.

Researchers are evaluating whether adding chemotherapy before surgery can improve outcomes for patients with high-risk dedifferentiated liposarcoma DDLPS and leiomyosarcoma LMS in the retroperitoneal area. This phase III trial compares standard surgery alone to surgery combined with chemotherapy, aiming to improve disease-free survival for these patients. The study is randomized and open-label, involving multiple centers. Participants are randomly assigned to one of two groups. The standard group undergoes large curative surgery within four weeks after randomization. The experimental group receives three cycles of chemotherapy tailored to their sarcoma typedoxorubicin and ifosfamide for high-grade liposarcoma, or doxorubicin and dacarbazine for leiomyosarcomastarting within two weeks of randomization, followed by a reassessment and surgery within three to six weeks after the last chemotherapy cycle. During the study, patients are closely monitored through imaging and pathology reviews to confirm tumor characteristics and treatment effects. Researchers measure disease-free survival over seven years, along with overall survival, recurrence rates, response to chemotherapy, side effects, complications, and quality of life for up to eight years. Participants provide tumor tissue and blood samples for research, and their health and safety are carefully tracked throughout the study period.

Researchers are evaluating dose-escalated radiation therapy compared to usual care for patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have already completed 4 to 6 months of chemotherapy. The study is a phase III trial aiming to determine if higher doses of radiation can improve 3-year overall survival, as well as assess effects on tumor progression, chemotherapy-free intervals, treatment toxicity, and quality of life. This trial is led by NRG Oncology and focuses on patients without disease progression after initial chemotherapy. Participants are randomly assigned to one of two groups. The first group receives standard care, which may include additional chemotherapy options such as FOLFIRINOX, NALIRIFOX, or gemcitabinenab-paclitaxel, standard radiation therapy with concurrent chemotherapy, or observation. The second group receives dose-escalated radiation therapy delivered in either 5 or 25 fractions, with or without concurrent chemotherapy for the 25-fraction option. After radiation, patients who have not completed 6 months of chemotherapy are encouraged to finish it, with treatment beyond 6 months at the physicians discretion. Imaging and tissue biopsies are performed throughout the study. Participants undergo various assessments including blood sample collection, CT scans, MRI, and optional PETCT scans before and during treatment. Tumor tissue biopsies are also collected. Follow-up visits occur every 3 months for the first 2 years and annually for an additional 3 years. Researchers measure overall survival, local disease progression, progression-free survival, chemotherapy-free intervals, and adverse events. Quality of life is evaluated using specific questionnaires over the course of participation.

Researchers are evaluating a phase II trial to study the use of personalized antibody-drug conjugates ADCs for treating patients with advanced or metastatic solid tumors that show high protein expression of Trop-2, nectin-4, or HER2. This trial aims to assess whether targeted treatments with sacituzumab govitecan, enfortumab vedotin, or trastuzumab deruxtecan work based on RNA and protein testing of tumor markers. These ADCs combine monoclonal antibodies with active drugs to target cancer cells more precisely. The study includes a two-step screening process. First, patients existing RNA test results are reviewed for expression of targets of interest TOIs. Then, protein expression is confirmed by immunohistochemistry IHC on previously collected tissue. Patients with high expression are assigned to one of three treatment cohorts receiving the corresponding ADC drug intravenously on specific schedules sacituzumab govitecan on days 1 and 8 every 21 days enfortumab vedotin on days 1, 8, and 15 every 28 days and trastuzumab deruxtecan on day 1 every 21 days. Imaging scans, biopsies, and blood sample collections are performed throughout the trial, with optional samples taken at progression. Echocardiography or MUGA scans are also used for patients receiving trastuzumab deruxtecan. Participants will undergo thorough assessments including CT and MRI imaging, tumor biopsies before and during treatment, blood collections, and heart function monitoring as applicable. Researchers will measure tumor response rates, progression-free survival, overall survival, molecular markers, and adverse events. After treatment ends, patients will be followed for up to three years with regular check-ins every 3 to 6 months to monitor outcomes and safety. This comprehensive monitoring helps understand the therapys impact and tumor changes over time.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are evaluating the combination of durvalumab, gemcitabine, and cisplatin given before surgery to treat patients with high-risk liver cancer called resectable intrahepatic cholangiocarcinoma. This phase II study aims to see how well patients complete this pre-surgery therapy and proceed to surgical removal of the tumor. The study also investigates tumor response, survival rates, and the safety and feasibility of the treatment approach. Participants receive durvalumab intravenously on day 1, with gemcitabine and cisplatin given intravenously on days 1 and 8, repeated every 21 days for 4 cycles before surgery. After surgery, patients may continue the same regimen for up to 4 more cycles if disease progression or unacceptable side effects do not occur. During the study, patients undergo CT and MRI scans, blood sample collection, and tissue biopsies at screening and during treatment. Throughout the study, participants are closely monitored with imaging and laboratory tests to evaluate tumor response and detect side effects. After completing treatment, patients have follow-up visits every 3 months for 2 years, then every 6 months for 5 years, and yearly afterward to assess survival and cancer recurrence. The main outcome measured is the proportion of patients who complete the pre-surgery therapy and surgery, with additional measures including pathological response, margin status after surgery, radiological response, overall and relapse-free survival, and adverse events.

Researchers are evaluating the effect of adding the drug tivozanib to the immunotherapy pembrolizumab compared to pembrolizumab alone in patients with high-risk renal cell carcinoma RCC. The study aims to determine whether this combination improves disease-free survival and overall survival. This phase III trial also assesses side effects, quality of life, and collects specimens for future research in patients who have undergone surgery to remove all known kidney cancer sites. In this study, participants are randomly assigned to one of two groups. One group receives pembrolizumab intravenously on specific days of each 12-week cycle for up to 4 cycles. The other group receives the same pembrolizumab schedule combined with oral tivozanib taken daily on specific days within the 12-week cycle for up to 6 months. Throughout the trial, participants undergo blood samples, MRI or CT scans, and may have tissue biopsies. After treatment, patients are followed regularly for up to 10 years to monitor outcomes. Participants will have scheduled visits during treatment cycles and follow-up visits every 4 months for 2 years, then every 6 months for 3 years, and annually for 5 more years. The research team measures disease recurrence or death disease-free survival as the main outcome, along with overall survival, side effects, treatment tolerance, and quality of life. Safety monitoring and quality of life assessments are included to evaluate the impact of the treatments over the long term.